This study is in progress, not accepting new patients

A Study of Zigakibart in Adults With IgA Nephropathy

a study on IgA Nephropathy Glomerulonephritis Kidney Disease Chronic Kidney Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)

Details

Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m2. The exploratory cohort will be randomized using the same schema as the primary cohort.

The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR.

Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period.

To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.

Keywords

IgA Nephropathy, Immunoglobulin A Nephropathy, Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease, IGA Glomerulonephritis, Chronic Renal Insufficiency, Urologic Diseases, BION-1301

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
  • Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
  • eGFR ≥ 30 mL/min/1.73m2 at Screening based on the 2021 CKD-EPI equation.
  • Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
  • Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.

You CAN'T join if...

  • Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
  • Diagnosis of IgA Vasculitis.
  • Current or history of nephrotic syndrome.
  • Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening.
  • Use of systemic immunosuppressant medications.
  • IgG levels < 6 g/L at Screening.

Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • UCSF
    San Francisco California 94143 United States
  • Valiance Clinical Research
    South Gate California 90280-5219 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05852938
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 383 people participating
Last Updated